Apparatus and System for Predictive Health Monitoring

ABSTRACT

An apparatus and system are provided for monitoring an individual, a group or a community of individuals for respiratory infections. Predictive health data, such as waking peak expiratory flow rate (“WPF”) and basal metabolic temperature (“BMT”) are measured and charted to provide an indication of early stage respiratory infection. Data may be collected for target populations and reported to health agencies for use in combating the spread of infection. An apparatus is provided which can simultaneously measure WPF and BMT and other health-condition-related values and automatically transmit readings to a data collection and analysis program on a remote computer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of patent application Ser. No.10/599,344 filed on Sep. 26, 2006, which claims priority under 35 U.S.C.§119 to PCT International Application No. PCT/US2005/010041 filed onMar. 24, 2005.

FIELD OF THE INVENTION

The present invention is related to health monitoring, and moreparticularly to an apparatus and system for monitoring individualsand/or populations to predict impending changes in respiratory healthand provide alerts to those changes.

BACKGROUND OF THE INVENTION

Many individuals are susceptible to respiratory infections includingbronchitis and pneumonia. In the United States alone, ordinary pneumoniakilled 62 thousand people in 1999. Asthmatics are particularlysusceptible to respiratory infections. 17 million people are known tohave asthma in the United States.

Infectious disease is the third leading cause of death in the UnitedStates. Moreover, deaths from infectious disease have been increasing.More Americans died per thousand due to infectious disease in 2000 thanin 1980. 90,000 people die each year in the United States due tonosocomial infections, many resulting from surgery. Individuals whoseimmune systems are compromised are particularly susceptible.

Peak flow meters are recommended to monitor the lung function value ofasthmatic's airways. This inexpensive device provides a non-invasive,inexpensive, convenient means to monitor lung function values and can beused at home by asthmatics of all ages. Peak flow meter readings fallbefore symptoms of asthma are otherwise noticed (providing earlydetection).

Body temperatures of 37.8° C. (100° F.) or above, are classified as afever. Fevers are described as low-grade [37.8° C. (100° F.) to 38.9° C.(102° F.)] or high-grade [above 39.5° C. (103° F.)]. When an infectionfirst occurs, the immune system causes white blood cells to move to thesite of the localized infection to fight the infection and the core bodytemperature of the individual begins to rise. As an infection spreads toother areas of an organ or other areas of the body and the number ofwhite blood cells involved in fighting the infection increases, causinga proportional increase in the body's core temperature. A spreadinginfection neither suddenly invades all susceptible tissues in the bodynor immediately involves all white blood cells. An infection spreadsover a period of time—different for different diseases and pathways.

Primary Prevention (i.e., taking steps to prevent the occurrence of aninfection) is, of course, important. However, because of travel,meetings, conventions, and the many other ways individuals come intocontact with large numbers of people, infections still occur.

Secondary Prevention is the early detection of an infection followed byactions taken immediately to reverse, halt or retard its progression(e.g., taking antiviral drugs, anti-oxidants or antibiotics). SecondaryPrevention can be very effective in protecting individuals from theadverse effects of infectious disease, but most therapeutic treatmentsare not optimally effective if they are not started during the earlystages of an infectious disease. Furthermore, detecting infections intheir very early stages has been difficult due to the fact that physicalsymptoms are often not yet apparent.

Accordingly, a need exists for an effective means for detecting andreporting impending respiratory infections.

SUMMARY OF THE INVENTION

An apparatus and system are provided for monitoring an individual, agroup, or a community of individuals for respiratory infections.Predictive health data, such as waking peak expiratory flow (WPF) andbasal metabolic temperature (BMT) are measured, charted and correlatedto provide an indication of early stage respiratory infection in anindividual. Data may be collected for target populations and reported tohealth agencies for use in combating the spread of infection in aneffected target population. An apparatus is provided which cansimultaneously measure WPF and BMT and automatically transmit readingsto a data collection and analysis program on a remote computer. Thesystem can further provide automatic reporting to individuals, theirdoctors, and/or health agencies.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the invention will be described with referenceto the accompanying drawings, of which:

FIG. 1 shows a predictive health monitoring chart for identifying earlystage respiratory infections in an individual according to an exemplaryembodiment of the invention;

FIG. 2 shows a system for collecting, transmitting, and reportingpredictive health monitoring data according to an exemplary embodimentof the invention;

FIG. 3 shows a health agency report for monitoring respiratoryinfections in populations according to an exemplary embodiment of theinvention; and

FIG. 4 shows an apparatus for reading and transmitting predictive healthmonitoring data according to an exemplary embodiment of the invention.

DETAILED DESCRIPTION OF THE EMBODIMENT(S)

The present invention provides an apparatus and system for monitoringindividuals and/or populations to predict impending changes inrespiratory health and provide alerts and/or reports of those changes.The inventors have determined that respiratory infections can bedetected by changes in BMT before other symptoms become discernable. Anabnormal elevation in BMT is a near-universal and early indication ofinfection. It is a precursor to symptoms, thus leading infectionsymptoms and speeding intervention. Early detection of a respiratoryinfection permits an earlier response, which typically results in abetter outcome. Not all changes in BMT, however, indicate respiratoryinfection, as cyclical physiological changes, stimulated by certainhormones released into the blood stream, increase and decrease basalmetabolism which results in a BMT that cycles up and down.

Basal metabolism is the level of metabolism needed for maintenance oflife when an individual is at digestive, physical and emotional rest,such as just before an individual rises in the morning. An elevatedbasal metabolism indicates that an infection may be present. BMT can bemeasured immediately upon waking after 6 to 8 hours of sleep. Normaldaytime body temperatures range from 98.6 to 100° F., depending on thelevel and type of activity. However, normal basal temperatures rangefrom 97.0 to 98.6° F. Physiological changes, stimulated by certainhormones released into the blood stream by endocrine glands, increasethe body's basal metabolic rate (BMR), which results in an increase inBMT. Other hormones regulate the stimulating hormones and effectivelyreduce BMR and therefore BMT. A cyclical BMT results, making accurateanalysis of raw values difficult unless properly scaled graphing isemployed such as described in the following section.

Predictive Charting Template

According to an exemplary embodiment of the present invention,Predictive Chart 1 is used to plot a BMT curve 10, rendering abnormalelevations of BMT, and therefore early infections, readily identifiable.The Predictive Chart 1 comprises a grid of squares comprising rowsextending in the horizontal and columns extending in the verticaldirection. The squares are divided into five vertically adjacenthorizontal bands, 12, 14, 16, 18, 20. The BMT curve 10 is plotted on thepredictive chart 1, with the columns corresponding to temporalincrements along a horizontal direction, such as, for example, onesquare for each day. In the vertical direction, the rows correspond totemperature increments, for example one tenth of one degree Fahrenheit(0.1° F.) for each square or row. BMT is tracked on Predictive Chart 1by entering a BMT reading for each day, so that cyclical fluctuationsand trends can be readily viewed along the horizontal direction ofPredictive Chart 1. The bands represent normal and elevated ranges forBMT. The first band 12 extends for twelve vertically adjacent rowscorresponding to temperatures from 96.9° F. to 98.1° F. and representsthe normal range for the BMT of a male. The second band 14, locateddirectly above the first band 12, extends for four vertically adjacentrows corresponding to temperatures from 98.1° F. to 98.5° F. andrepresents a first elevated range for BMT, still normal for a female'sBMT during the luteal phase of her reproductive cycle. A BMT in thesecond band 14 does not provide an accurate indication of infection forfemales, because BMT in band 14 is common during physiological changes,such as menstruation, but it does for males. The third band 16, locateddirectly above the second band 14, extends for four vertically adjacentrows corresponding to temperatures from 98.5° F. to 98.9° F. andrepresents a second elevated range for BMT. This second elevated rangefor BMT generally indicates an abnormal elevation, and BMT 10 in thethird band 16 is an indication of the early stages of an infection. Thefourth band 18 extends for four vertically adjacent rows correspondingto temperatures from 98.9° F. to 99.3° F., and the fifth band 20 extendsupward from 99.3° F. The fourth and fifth bands 18, 20 of PredictiveChart 1 represent additional elevated ranges for BMT and are alsoindicative of early stages of an infection.

In an exemplary embodiment of the invention, the horizontal bands 12,14, 16, 18, 20 are color coded, for example, the first band 12 beingpastel blue, the second band 14 being pastel pink, the third band 16being yellow, the fourth band 18 being pastel green and the fifth band20 being gray. The color coding enables healthcare workers, patients,and others to easily and accurately determine which band a particularBMT reading falls within, and thus determine whether that particular BMTreading is in the second, third, or fourth elevated ranges of the third16 fourth 18 and fifth 20 bands, respectively, indicating early stageinfection. As shown in FIG. 1, a BMT reading 31 of 98.9° F. was recordedfor Dec. 5, 2002, which is plotted in the third band 16, indicating theearly stages of an infection.

In an exemplary embodiment of the invention, a waking peak flow (WPF)curve 30 is also plotted on Predictive Chart 1. The normal range forwaking peak flow, 80% to 100% of Peak Best (the best flow rate producedby the individual), is arranged to correspond to the fourth band 18,with daily WPF measurements plotted for each day and each verticallyadjacent row of squares corresponding to a 5% increment in WPFmeasurements. As shown in FIG. 1, the third band 16 corresponds toabnormally low WPF readings of from 60% to 80%, indicative of adepressed respiratory condition. By correlating BMT and WPF, aparticularly accurate indicator of a respiratory infection is providedwhich may be observed up to days before physical symptoms areexperienced. When BMT rises into a band corresponding to abnormally highBMT (here the third, fourth, and fifth bands 16, 18, 20, respectively)and WPF readings simultaneously fall in a band corresponding toabnormally low WPF (here, also the third band 16), it is a strongindication of a respiratory infection. This indication typically occursbefore other symptoms of respiratory infection are present, such as:fever, headache, tiredness [can be extreme], dry cough, sore throat,nasal congestion, body aches, etc. A physician can test to determine ifthe individual being monitored has the flu or there is some other causalfactor. As shown in

FIG. 1, on Dec. 7, 2002, the WPF curve 10 dropped into the third band 16while the BMT curve 30 rose into the fourth band 18. Moreover, due tothe arrangement of Predictive Chart 1, the BMT curve 30 and the WPFcurve 10 cross each other at point 32 (during Dec. 6, 2002), providing astrong and easily recognizable indication of a respiratory infection.

In an ideal embodiment of the invention, waking heart rate (WHR), wakingsaliva acidity (WPh) and waking blood oxygen (WO2) curves are alsoplotted on Predictive Chart 1, because they too indicate the generalhealth condition of the person being monitored.

Optionally, a last reading window 50 may be provided for presenting themost recent measurements in numerical form. In FIG. 1 for example, themost recent BMT reading of 97.7° F. and the most recent peak flowreading of 380 PF (peak-flow) are presented. These numerical values helphealthcare workers to quickly evaluate the health of the person beingmonitored.

Predictive Health Monitoring Data Collection and Reporting System

According to an exemplary embodiment of the present invention, a systemis provided for recording, transmitting (i.e., forwarding to a remotecomputer system), storing and reporting predictive health monitoringdata to facilitate secondary prevention (i.e., the early detection andtreatment) of respiratory infections, such as influenza, bronchitis,pneumonia, and SARS). As shown in FIG. 2, actual health monitoring data(in the present embodiment, BMT and WPF readings) are entered into atelephone 110 or a personal computer 120 and transmitted to a datacollection and analysis program on a health monitoring computer 130through a central telephone network 111 or the Internet 121,respectively. The data collection and analysis program on the healthmonitoring computer 130 then uses the health monitoring data to create achart 1, which can be accessed by the individual being monitored or thatindividual's personal physician or others, so that indications of earlystage respiratory infections can be identified and secondary preventioncan be initiated. The monitored individual or physician may, forexample, access the chart 1 through the Internet 121 on a personalcomputer 122.

The data collected by the data collection and analysis program on thehealth monitoring computer 130 can be protected by password or othermeans known in the art to maintain confidentiality of individual medicalrecords in compliance with HIPAA.

Health Agency Report

As shown in FIG. 2, a health agency report 2 may also be created by thedata collection and analysis program on the health monitoring computer130, and accessed on a personal computer 122 by health agencyrepresentatives. This health agency report 2 can be used by healthagency personnel to track the spread of respiratory infections and tofacilitate remedial actions, such as broadcast alerts and screening, aswell as allocation of anti-viral or antibiotic medications.

An exemplary embodiment of the health agency report 2 is shown in FIG.3. In this exemplary embodiment, predictive health monitoring data iscollected throughout the Commonwealth of Pennsylvania, and presented bycounty. Referring, for example, to Lawrence County, the population ofLawrence County is provided as a raw number (94,643) and as a percentageof the total population of Pennsylvania (0.7%). The number of sentries(i.e., participants in the predictive health monitoring program) forLawrence County are provided as a raw number (1,420) and as a percentageof the Lawrence County population (1.5%). Next, the number of sentriesreporting predictive health monitoring readings for the day of thereport are presented as a raw number (1,250) and as a percentage ofsentries in Lawrence County (88%). Thus the significance of the data canbe determined, and the integrity of the system can be monitored.

Below the aforementioned regional statistics, the actual readings formonitored individuals are presented in a three row by five column table.The three rows from top to bottom correspond to WPF readings in thefourth band 18 (indicating normal WPF), the third band 16 (indicatingbelow normal WPF—less than 80% of Peak Best), and the second band 14(also indicating below normal WPF—less than 60%), respectively. The fivecolumns from left to right correspond to BMT readings in the first band12 (normal BMT—temperatures of from 96.9° F. to 98.1° F.), the secondband 14 (temperatures of from 98.1° F. to 98.5° F.), the third band 16(temperatures of from 98.5° F. to 98.9° F.), the fourth band 18(temperatures of from 98.9° F. to 99.3° F.), and the fifth band 20(temperatures greater than 99.3° F.), respectively. The numbers in eachcell of the matrix represent the raw number and percentage of thereporting sentries for the county that reported a WPF reading in theband corresponding to the particular row and reported a BMT reading inthe band corresponding to the particular column. For example, forLawrence County on the day of the report shown in FIG. 3, 13 sentries(1.04% of sentries reporting for Lawrence County) reported a WPF in thethird band 16 (between 60% and 80%) and a BMT in the fourth band 18(between 98.9° F. to 99.3° F.). While the foregoing example includesthree bands for WPF and five bands for BMT, other arrangements usingfewer or additional bands are contemplated within the scope of theinvention, provided, however that at least one band corresponds to anormal range for each measured characteristic and at least one bandcorresponds to an abnormal range for each measured characteristic.

A threshold value can be set for particular cells in the table, and thecells can be highlighted when those thresholds are reached. For example,as shown in FIG. 4, the four cells in the lower right of the table forLawrence County are highlighted, indicating a number or percentage ofoccurrences or events above a set threshold. As shown in FIG. 3, thehealth agency report 2 only tracks predictive health monitoring readingstatistics for a population, and therefore individual readings are notshown, maintaining confidentiality of individual medical records.

Apparatus for Measuring WPF/BMT

It is important for effective predictive health monitoring, that the BMTand WPF be taken immediately when an individual is awakened. It isfurther necessary that the readings be accurately entered into the datacollection and analysis program on the health monitoring computer 130.In an exemplary embodiment of the invention, an apparatus and method areprovided for accurately taking and entering BMT and WPF readings. Acombination peak flow meter and basal thermometer (WPF/BMT device) 200is provided according to an exemplary embodiment of the invention. TheWPF/BMT device comprises a housing 210 having an upper housing portion211 and a lower housing portion 212, which are attached by a suitablefastening means, such as screws and/or snap geometry. A flow meter 220is disposed between the upper and lower housing portions 211, 212,defining a fluid flow channel 221. The fluid flow channel 221 isenclosed to contain a fluid (exhalation in the present example) and maybe bounded on one or more sides by one or both housing portions 211,212. An impellor 223 is disposed in the fluid channel, such that it isrotated by the fluid that passes through the fluid channel. The impellor223 may, for example, include a permanent magnet. The peak flow rate(PFR) may be determined, for example, by a field-effect transistor 231that senses the rotating magnet within the impellor 223. Thefield-effect transistor 231 is mounted on a printed circuit board (PCB)230 and the peak flow reading is read by counting the number ofrotations of the impellor 223 per second. The information is storeddigitally in a memory device on the PCB 230. A mouthpiece 240 isconfigured to be placed in the mouth and form a fluid tight seal duringexhalation to direct exhaled fluid into the flow channel 221 to measurePFR.

A rapid electronic thermometer probe 250 is disposed in the mouthpiece240 and electrically connected to the PCB 230 to measure basal metabolictemperature and provide a digital value to the memory device on the PCB230. Thus, WPF and BMT can be measured simultaneously, by placing themouthpiece 240 of the WPF/BMT device 200 into the mouth and, after BMTis acquired, forcefully exhaling.

The PCB may also have a connector 235, which readily mates with astandard phone plug, for automatic transmission of the stored digitalvalues for WPF and BMT. Thus, digitally recorded values can betransmitted over a telephone network 111 or the Internet 121 withoutkeying numbers or verbal communication, eliminating a significant sourceof data entry errors, enhancing the convenience and accuracy of thepredictive monitoring system.

In an exemplary embodiment of the invention a means to detect wakingheart rate (WHR), waking saliva acidity (WPh) and/or waking blood oxygen(WO2) are also incorporated in the WPF/BMT device 200. The WPF/BMTdevice 200 may include a detection device 260 comprising a sensingmodule (Sensing Module) which includes a light source of two wavelengths, such as 650 nm and 805 nm as used in pulse oximetry, a detectoror multiple detectors capable of sensing the two near infraredwavelengths of light as well as infrared radiation and an electroniccircuit with firmware capable of determining with relative (i.e.,reading to reading) accuracy the heart rate and percentage of oxygensaturation observed by the sensing module when an individual's finger orthumb is brought in close proximity to the Sensing Module.

Also in an exemplary embodiment of the invention a second probe (WPhProbe) 270 disposed in the mouthpiece 240 and electrically connected tothe PCB 230, similar to the basal thermometer probe in the exemplaryembodiment, may be incorporated to (i) assist the person being monitoredin accurately positioning both probes in the mouth on each side of thebottom of the tongue and (ii) provide waking saliva acidity (WPh)readings by determining the galvanic potential or electrical resistancebetween the metal tip of the basal thermometer probe and the metal tipof the WPh Probe 270.

Description of Operation

In an exemplary embodiment of the invention, the WPF/BMT device 200 orother discrete means to measure WPF and BMT are placed by anindividual's bedside near or next to a waking device (e.g., alarmclock). Upon waking, WPF and BMT are acquired under basal conditions(and in an ideal embodiment of the invention WHR, WPh and WO2 are alsoacquired) by the individual or their caretaker and forwarded to the datacollection and analysis program on a health monitoring computer 130(i.e., Remote System) either automatically (as described above) ormanually by any convenient means such as phone, email, or Internetwebsite. The data forwarded may also include the individual's answers tohealth-related questions.

The Remote System receives the daily readings and answers tohealth-related questions and stores the reading values and other datausing a code number or numbers to identify the data stored. If anInternet website page is used to enter the data, a page may be displayedconfirming that the data was received, which page may also includeimmediate analytical information and recommendations based on the datasubmitted. The same analytical information and recommendations may beobtained from an auto-attendant if a telephone is used to enter data orfrom email software designed to respond in the same manner to emailsubmissions.

Either when requested or as soon as new data is received, the RemoteSystem will graph the individual's correlated data, i.e., WPF, BMT,etc., on a predictive health monitoring chart 1 and health agency report2 with answers to health-related questions, and upload the predictivehealth monitoring chart 1 and health agency report 2, so that they maybe viewed on the Internet or emailed to the individual, healthcarepersonnel, and/or government officials.

The foregoing illustrates some of the possibilities for practicing theinvention. Many other embodiments are possible within the scope andspirit of the invention. It is, therefore, intended that the foregoingdescription be regarded as illustrative rather than limiting, and thatthe scope of the invention is given by the appended claims together withtheir full range of equivalents.

What is claimed is:
 1. A chart for graphing Basal Metabolic Temperaturefor use in early identification of infections, the chart comprising twoor more visually distinct horizontal bands with a transverse directionof the bands corresponding to increments of temperature and alongitudinal direction of the bands corresponding to an increments oftime, one of said visually distinct horizontal bands having a widthcorresponding to a normal range for basal metabolic temperature and atleast one other horizontal band corresponding to an abnormally elevatedrange for basal metabolic temperature.
 2. The chart of claim 1 wherein agrid of squares extend in horizontal rows and vertical columns, and therows are separated into five visually distinct horizontal bands withthree of said bands corresponding to abnormally elevated ranges forbasal metabolic temperature.
 3. The chart of claim 1 wherein visuallydistinct horizontal bands are shaded with different colors.
 4. The chartof claim 2 wherein the rows are separated into three or more visuallydistinct horizontal bands with each row corresponding to an increment oftemperature and to an increment of fluid flow and each columncorresponding to an increment of time, a first one of said visuallydistinct horizontal bands corresponding to a normal range for basalmetabolic temperature, a second one of said visually distinct horizontalbands corresponding to a normal range for waking peak flow of exhaledfluid and at least one other horizontal band corresponding to anabnormally elevated range for basal metabolic temperature and anabnormally low range for waking peak flow whereby basal metabolictemperature and waking peak flow may be charted simultaneously toindicate correlations in abnormal readings to detect respiratoryinfections.
 5. A system for measuring, transmitting, and reportingpredictive health monitoring data, comprising: an apparatus formeasuring at least one of basal metabolic temperature and waking peakflow; a computer program for recording measured values for at least oneof basal metabolic temperature and waking peak flow; a means fortransmitting the measured values for at least one of basal metabolictemperature and waking peak flow to said computer program; and one ormore compilations of the measured data for at least one individual or apopulation for use in predictive health monitoring.
 6. A health agencyreport showing reported tabulated values of predictive health monitoringdata of individuals for monitoring infections, including respiratoryinfections, in one or more identified populations, comprising a matrixof cells arranged in horizontal rows and vertical columns, the rowscorresponding to a first one of basal metabolic temperature and wakingpeak flow ranges and the columns corresponding to the other of basalmetabolic temperature and waking peak flow ranges, wherein each cellcontains at least one of raw numbers of individual's and percentage ofindividuals reporting values for basal metabolic temperature and wakingpeak flow in the ranges corresponding to that cell.
 7. An apparatus forsimultaneously measuring basal metabolic temperature and waking peakflow, the apparatus comprising: a fluid channel for passing exhaledfluid and having an impellor disposed therein for measuring peakvolumetric flow of fluid through the fluid channel by sensing therotating magnet within the impellor with a field-effect transistorcounting the numbers of rotation per second of the impellor; amouthpiece for insertion into an individual's mouth and forming a sealwith the mouth and directing exhaled fluid through the fluid channel; arapid thermometer disposed in the mouthpiece for measuring basalmetabolic temperature when the mouthpiece is inserted into the mouth;and a digital memory for storing measured values for basal metabolictemperature and waking peak flow.
 8. The apparatus of claim 7 furthercomprising a connector for transmitting the measured values for basalmetabolic temperature and waking peak flow to a remote location.
 9. Theapparatus of claim 7 further comprising a wireless means fortransmitting the measured values for basal metabolic temperature andwaking peak flow to a remote location.